ACTIQ is indicated for the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.Limitations of Use:
ACTIQ may be dispensed only to patients enrolled in the TIRF REMS Access program.

Important Safety Information

RESPIRATORY DEPRESSION Fatal respiratory depression has occurred in patients treated with ACTIQ, including following use in opioid non-tolerant patients and improper dosing. The substitution of ACTIQ for any other fentanyl product may result in fatal overdose.

Due to the risk of respiratory depression, ACTIQ is contraindicated in the management of acute or postoperative pain including headache/migraine and in opioid non-tolerant patients.

Death has been reported in children who have accidentally ingested ACTIQ. ACTIQ must be kept out of reach of children.

The concomitant use of ACTIQ with CYP3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression.

MEDICATION ERRORS Substantial differences exist in the pharmacokinetic profile of ACTIQ compared to other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl that could result in fatal overdose.- When prescribing, do not convert patients on a mcg per mcg basis from any other fentanyl products to ACTIQ. - When dispensing, do not substitute an ACTIQ prescription for other fentanyl products.

ABUSE POTENTIAL ACTIQ contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. ACTIQ can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing ACTIQ in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion.

Because of the risk for misuse, abuse, addiction, and overdose, ACTIQ is available only through a restricted program required by the Food and Drug Administration, called a Risk Evaluation and Mitigation Strategy (REMS). Under the Transmucosal Immediate Release Fentanyl (TIRF) REMS Access program, outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors must enroll in the program. Further information is available at www.TIRFREMSAccess.com or by calling 1-866-822-1483.

Indication: ACTIQ is indicated for the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.
Limitations of Use:
ACTIQ may be dispensed only to patients enrolled in the TIRF REMS Access program.

The following is not a complete list; please see full prescribing information.

Contraindications:

ACTIQ is contraindicated in opioid non-tolerant patients. Life-threatening respiratory depression and death can occur at any dose in opioid non-tolerant patients

ACTIQ is contraindicated in the management of acute or postoperative pain including headache/migraines and dental pain

ACTIQ is contraindicated in patients with known intolerance or hypersensitivity to any of its components or the drug fentanyl

ACTIQ is not bioequivalent to other fentanyl products. Do not convert patients on a mcg per mcg basis from other fentanyl products

Full and partially consumed ACTIQ units contain a medicine in an amount which can be fatal to a child. Death has been reported in children who have accidentally ingested ACTIQ. Ensure proper storage and disposal. Interim safe storage container available (“ACTIQ Child Safety Kit”)